Download Provincial Cervical Cancer Treatment Guidelines

Provincial Cervical Cancer Treatment Guidelines
Approved at the Provincial Gyne-Oncology Guideline Meeting
January 11, 2013
Clinical practice guidelines have been developed after multi-disciplinary consensus
based on best available literature. As the name suggests, these are to be used as a
guide only. These guidelines do not replace physician judgment which is based on
multiple factors including, but not limited to, the clinical and social scenario,
comorbidities, performance status, age, available resources and funding considerations.
The Saskatchewan Cancer Agency disclaims all liability for the use of guidelines except
as expressly permitted by the Agency. No portion of these guidelines may be copied,
displayed for redistribution to third parties for commercial purposes or any nonpermitted use without the prior written permission from the Agency.
Recommendations for drug treatment presented in the Cancer Agency guidelines for a
cancer site may not reflect provincial cancer drug funding. Please refer to the current
Saskatchewan Cancer Agency drug formulary at www.saskcancer.ca for information on
cancer drug listing and funding.
Benefits and risk of the proposed should be discussed with patient.
Participating in clinical trials is encouraged when available. Involvement of a
multidisciplinary team is strongly recommended.
Screening.
Screening can prevent cervical cancer by finding abnormal cell changes that can be
treated at an early stage before cancer develops and is strongly advised. Please refer to
Prevention Program for Cervical Cancer at www.saskcancer.ca.
Referral:
All patients with a positive diagnosis should be referred to a gyne-oncologist, with all
physical pertinent information provided, for discussion at multi-disciplinary tumour board
rounds who will triage patient for further management.
Diagnosis and Work-up:

History and clinical examination, including pelvic examination

Cervical biopsy; pathology review should be performed by a pathologist with
experience in gynecologic pathology. Cone biopsy as indicated

Blood work (CBC, LFT, renal function studies)

Examination under anesthesia (EUA), cystoscopy/proctoscopy if necessary
Imaging (optional for ≤ stage IB1) can include: MRI pelvis, CT abdomen; chest
x-ray; CT/PET optional

PET scan is suggested for patients with FIGO IIB-IVA and/or pelvic /paraortic
lymphadenopathy suspicious for metastases.
Staging:
The Féderation Internationale de Gynécologie et d’Obstétrique (FIGO)
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Saskatchewan Cancer Agency Cervical Cancer Treatment Guidelines
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Stage
I
(T1)
The carcinoma is strictly confined to the cervix (extension to the corpus would be
disregarded).
IA (T1a)
Invasive carcinoma, which can be diagnosed only by microscopy with deepest invasion ≤5
mm and largest extension ≥7 mm.
IA1
(T1a1)
Measured stromal invasion of ≤3.0 mm in depth and extension of ≤7.0 mm.
IA2
(T1a2)
Measured stromal invasion of >3.0 mm and not >5.0 mm with an extension of not >7.0 mm.
IB
(T1b)
Clinically visible lesions limited to the cervix uteri or preclinical cancers greater than stage
IA.b
IB1
(T1b1)
Clinically visible lesion ≤4.0 cm in greatest dimension.
IB2
(T1b2)
Clinically visible lesion >4.0 cm in greatest dimension.
II
(T2)
Cervical carcinoma invades beyond the uterus but not to the pelvic wall or to the lower third
of the vagina.
IIA
(T2a)
Without parametrial invasion.
IIA1
(T2a1)
Clinically visible lesion ≤4.0 cm in greatest dimension.
IIA2
(T2a2)
Clinically visible lesion >4.0 cm in greatest dimension.
IIB
(T2b)
With obvious parametrial invasion.
III
(T3)
The tumour extends to the pelvic wall and/or involves lower third of the vagina and/or causes
hydronephrosis or nonfunctioning kidney.c
IIIA
(T3a)
Tumour involves lower third of the vagina with no extension to the pelvic wall.
IIIB
(T3b)
Extension to the pelvic wall and/or hydronephrosis or nonfunctioning kidney.
IV
(T4)
The carcinoma has extended beyond the true pelvis or has involved (biopsy proven) the
mucosa of the bladder or rectum. A bullous edema, as such, does not permit a case to be
allotted to stage IV.
IVA
(T4)
Spread of the growth to adjacent organs.
IVB
(M1)
Spread to distant organs.
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Management of Invasive Carcinoma of Cervix:
FIGO IA1
-
Conization with free margins for cancer without LVI
Trachelectomy
Simple hysterectomy
Modified radical hysterectomy
FIGO IA2
Conizationwithpelvic lymphadenectomy - Simple or modified radical hysterectomy with
pelvic lymphadenectomy +/- PALND
Radical trachelectomy for fertility preservation with pelvic lymphadenectomy +/- PALND
Lymphovascular space involvement, consider pelvic lymphadenectomy.
Radiation should be reserved for women who are not surgical candidates
FIGO IB1
Radical hysterectomy + pelvic lymphadenectomy +/- PALND;
Adjuvant post-operative radiotherapy is considered only when adverse pathological
findings are found
Radical trachelectomy + pelvic lymphadenectomy +/- PALND could be considered for
patients wishing fertility preservation
Pelvic RT + HDR brachytherapy. To be considered for woman who are not candidates
for surgery. Concurrent chemo- radiation may be considered.
FIGO IB2
Preferred Approach: Pelvic RT + concurrent chemotherapy (cisplatin × 5 - 6 cycles) ;
HDR brachytherapy
Radical hysterectomy + pelvic lymphadenectomy +/- PALND for women who are not
candidates for pelvic radiation.
Adjuvant post-operative radiotherapy is considered only when adverse pathological
findings are found
FIGO IIA1
Radical hysterectomy + pelvic lymphadenectomy +/- PALND
Adjuvant post-operative radiotherapy is considered only when adverse pathological
findings are found
or
Pelvic RT + concurrent chemotherapy (cisplatin × 5 - 6 cycles) ; HDR Brachytherapy for
women who are not candidates for surgery.
FIGO IIA2
Pelvic RT + concurrent chemotherapy (cisplatin × 5 - 6 cycles) ; HDR brachytherapy
Hysterectomy is not recommended because of excessive morbidity and no overall
survival benefit.
FIGO IIB/IIIA/IVA
-
Pelvic RT+ concurrent chemotherapy (cisplatin × 5-6 cycles); HDR brachytherapy.
-
Parametrial boost may be considered.
Paraaortic radiation for CT/MRI/PET or biopsy positive paraaortic lymphadenopathy.
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Saskatchewan Cancer Agency Cervical Cancer Treatment Guidelines
-
Approved January 2013
Hysterectomy for women who had a poor response to chemoradiation or have evidence
of persistent disease following chemoradiation. Routine hysterectomy after
chemoradiation is not recommended.
At this stage, there is no evidence for adjuvant chemotherapy but the results as per clinical trials
are awaited.
FIGO IVB
Clinical trial
Palliative chemotherapy cisplatin based
Palliative Radiation therapy
Post-operative Adjuvant Therapy Indications:
When deciding on adjuvant treatment options:
Intermediate Risk Adverse features:
Tumour size
Depth of stromal invasion
Lymphovascular space invasion (LVSI)
Pelvic Radiation + HDR Brachytherapy Indications:
- LVSI plus deep one-third cervical stromal invasion and tumour of any size
- LVSI plus middle one-third stromal invasion and tumour size ≥2 cm
- LVSI plus superficial one-third stromal invasion and tumour size ≥5 cm
- No LVSI but deep or middle one-third stromal invasion and tumour size ≥4 cm
High Risk Adverse features:
Nodal status positive
Parametrial involvement
Positive surgical margins
Concurrent Pelvic/para-aortic radiation and Cis-Platinum Chemotherapy + HDR
indications:
- One feature or more
Radiation Therapy:
Pelvic RT: 45 – 50.4 Gy in 25 – 28 fractions (1.8 to 2.0 Gy per fraction) over 5-5.5 weeks
Boost to the parametria 3-5 fractions may be given as clinically indicated.
Para-aortic radiation may be considered for CT or PET positive lymphadenopathy or
biopsy positive paraaortic lymph nodes
Brachytherapy- HDR :
Intracavitary brachytherapy 3000cGy in 5 fractions. CT or MRI volume based.
Vaginal HDR Brachytherapy 1200-1500cGy/3 fractions
Vaginal brachytherapy as single modality 2100cGy/3 fractions
Interstitial HDR Brachytherapy may be considered in selected cases.
3D conformal or IMRT boost may be considered for women who are not intracavitary
HDR or surgical candidates.
An attempt should be made for Radiation therapy to be completed within 8 weeks from the start
of chemo-RT.
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It is recommended to maintain adequate hemoglobin during radiotherapy > 100 g/l however
use of Erythropoeitin is not recommended as it is shown to decrease the survival
Concurrent Chemotherapy:
Cisplatin 40 mg/m2 (max = 80) IV weekly for 5 - 6 cycles during EBRT
Follow up:
Recommendation to use vaginal dilator after pelvic radiation
Physical examination and review of symptoms every 3 - 4 months for the first
three Years by a GyneOncologist or Radiation Oncologist. After 3 years, all
patients will be followed by the Family Physician every 6 months for 2 years and
then annually thereafter.
Pap test/vaginal vault cytology annually. - MRI, CT and/or PET if recurrence
suspected
Laboratory assessment as indicated
Management of Local Recurrence/Metastases
History and clinical examination
Blood work (CBC, LFT, renal function,)
Chest x-ray;CT; MRI of pelvis; CT-PET
Treatment options:
Recurrence in the pelvis following radical surgery may be considered for
radiation in combination with chemotherapy.
Central recurrence after radical radiotherapy may be considered for radical
surgery, e.g., pelvic exenteration.
Incurable pelvic recurrence/distant metastases:
- Clinical trial
- Palliative chemotherapy with platinum dublet is the preferred option.
Platinum refractory patients can be treated with other agents.

First Line
Paclitaxel 175 mg/m2 IV Day 1 plus Carboplatin AUC = 6 (if no prior RT) or AUC
= 5 (if prior RT) IV Day 1 every 3 weeks
Cisplatin 50 mg/m2 IV Day 1 plus Topotecan 0.75 mg/m2 IV Days 1,2,3 every 3
weeks (Dr. Al-Hayki has used this regimen, but I don’t think this was discussed
at the guideline meeting, and it does not seem to be listed in the latest UpToDate
summary)


Second Line
Vinorelbine 25-30 mg/m2 IV Day 1 and 8 every 3 weeks
Topotecan 1.5 mg/m2 IV Days 1,2,3,4,5 every 3 weeks

-
Palliative radiation therapy
Pregnancy:
During pregnancy, no therapy is warranted for pre-invasive lesions of the cervix,
including carcinoma in situ, though expert colposcopy is recommended to exclude
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invasive cancer. Treatment of invasive cervical cancer during pregnancy depends on
the stage of the cancer and gestational age at diagnosis. The traditional approach is to
recommend immediate therapy appropriate for the disease stage when the cancer is
diagnosed before fetal maturity and to delay therapy only if the cancer is detected in the
final trimester.[13,14] However, other reports suggest that deliberate delay of treatment
to allow improved fetal outcome may be a reasonable option for patients with stage IA
and early IB cervical cancer. The decision on management lies with the patient in
careful consultation with the oncologist. The factors to consider are the natural history of
the cancer process, the gestational age and the wishes of the parents.
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References:
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2. Jones WB, Mercer GO, Lewis JL Jr, et al.: Early invasive carcinoma of the cervix.
Gynecol Oncol 51 (1): 26-32, 1993. [PUBMED Abstract]
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mm invasion): risk factors and prognosis. A Gynecologic Oncology Group study. Am J
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cervix: stage IA and carcinoma in situ. Int J Radiat Oncol Biol Phys 21 (2): 375-8, 1991.
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16. Hopkins MP, Morley GW: The prognosis and management of cervical cancer associated
with pregnancy. Obstet Gynecol 80 (1): 9-13, 1992. [PUBMED Abstract]
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treatment of invasive disease. Am J Obstet Gynecol 199 (1): 10-8, 200 Sevin BU, Nadji
M, Averette HE, et al.: Microinvasive carcinoma of the cervix. Cancer 70 (8): 2121-8,
1992. [PUBMED Abstract]
18. Jones WB, Mercer GO, Lewis JL Jr, et al.: Early invasive carcinoma of the cervix.
Gynecol Oncol 51 (1): 26-32, 1993. [PUBMED Abstract]
19. Creasman WT, Zaino RJ, Major FJ, et al.: Early invasive carcinoma of the cervix (3 to 5
mm invasion): risk factors and prognosis. A Gynecologic Oncology Group study. Am J
Obstet Gynecol 178 (1 Pt 1): 62-5, 1998. [PUBMED Abstract]
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cervix: stage IA and carcinoma in situ. Int J Radiat Oncol Biol Phys 21 (2): 375-8, 1991.
21. Landoni F, Maneo A, Colombo A, et al.: Randomised study of radical surgery versus
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lymph nodes in stages IIB and bulky IB and IIA cervical carcinomas. Ten-year treatment
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27. Fine BA, Hempling RE, Piver MS, et al.: Severe radiation morbidity in carcinoma of the
cervix: impact of pretherapy surgical staging and previous surgery. Int J Radiat Oncol
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28. Estape RE, Angioli R, Madrigal M, et al.: Close vaginal margins as a prognostic factor
after radical hysterectomy. Gynecol Oncol 68 (3): 229-32, 1998. [PUBMED Abstract]
29. Whitney CW, Sause W, Bundy BN, et al.: Randomized comparison of fluorouracil plus
cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB-IVA
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30. Lertsanguansinchai P, Lertbutsayanukul C, Shotelersuk K, et al.: Phase III randomized
trial comparing LDR and HDR brachytherapy in treatment of cervical carcinoma. Int J
Radiat Oncol Biol Phys 59 (5): 1424-31, 2004. [PUBMED Abstract]
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31. Nag S, Erickson B, Thomadsen B, et al.: The American Brachytherapy Society
recommendations for high-dose-rate brachytherapy for carcinoma of the cervix. Int J
Radiat Oncol Biol Phys 48 (1): 201-11, 2000. [PUBMED Abstract]
32. Akila N. Viswanathan, Bruce Thomadsen, American Brachytherapy Society Cervical
Cancer Recommendations Committee. American Brachytherapy Society consensus
guidelines for locally advanced carcinoma of the cervix. Part I: General principles.
Brachytherapy 11 (2012) 33-46
33. Akila N. Viswanathan, Sushil Beriwal2, Jennifer F. De Los Santos3, D. Jeffrey Demanes,
American Brachytherapy Society consensus guidelines for locally advanced carcinoma
of the cervix. Part II: High-dose-rate brachytherapy. Brachytherapy 11 (2012) 47-52
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lymph nodes in stages IIB and bulky IB and IIA cervical carcinomas. Ten-year treatment
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36. Thigpen JT, Blessing JA, DiSaia PJ, et al.: A randomized comparison of a rapid versus
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cisplatin plus mitolactol versus cisplatin plus ifosfamide in advanced squamous
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44. Rose PG, Blessing JA, Gershenson DM, et al.: Paclitaxel and cisplatin as first-line
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45. Burnett AF, Roman LD, Garcia AA, et al.: A phase II study of gemcitabine and cisplatin
in patients with advanced, persistent, or recurrent squamous cell carcinoma of the
cervix. Gynecol Oncol 76 (1): 63-6, 2000. [PUBMED Abstract]
46. Long HJ 3rd, Bundy BN, Grendys EC Jr, et al.: Randomized phase III trial of cisplatin
with or without topotecan in carcinoma of the uterine cervix: a Gynecologic Oncology
Group Study. J Clin Oncol 23 (21): 4626-33, 2005. [PUBMED Abstract]
47. Tumours of the cervix. In: Morrow CP, Curtin JP: Synopsis of Gynecologic Oncology. 5th
ed. New York, NY: Churchill Livingstone, 1998, pp 107-151.
48. Tewari KS, Monk BJ: Gynecologic oncology group trials of chemotherapy for metastatic
and recurrent cervical cancer. Curr Oncol Rep 7 (6): 419-34, 2005. [PUBMED Abstract]
49. Monk BJ, Huang HQ, Cella D, et al.: Quality of life outcomes from a randomized phase
III trial of cisplatin with or without topotecan in advanced carcinoma of the cervix: a
Gynecologic Oncology Group Study. J Clin Oncol 23 (21): 4617-25, 2005. [PUBMED
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50. Monk BJ, Sill M, McMeekin DS, et al.: A randomized phase III trial of four cisplatin (CIS)
containing doublet combinations in stage IVB, recurrent or persistent cervical carcinoma:
a Gynecologic Oncology Group (GOG) study. [Abstract] J Clin Oncol 26 (Suppl 15): ALBA5504, 2008.
51. Sutton GP, Blessing JA, McGuire WP, et al.: Phase II trial of ifosfamide and mesna in
patients with advanced or recurrent squamous carcinoma of the cervix who had never
received chemotherapy: a Gynecologic Oncology Group study. Am J Obstet Gynecol
168 (3 Pt 1): 805-7, 1993. [PUBMED Abstract]
52. Monk BJ, Sill MW, Burger RA, et al.: Phase II trial of bevacizumab in the treatment of
persistent or recurrent squamous cell carcinoma of the cervix: a gynecologic oncology
group study. J Clin Oncol 27 (7): 1069-74, 2009. [PUBMED Abstract]
53. Elit L, Fyles AW, Devries MC, et al, and The Gynecology Cancer Disease Site Group.
Follow-up for women after treatment for cervical cancer: A systematic review.
Gynecologic Oncology 114 (2009) 528–535.
54. FIGO Committee on Gynecologic Oncology. Revised FIGO staging for carcinoma of the
vulva, cervix, and endometrium. International Journal of Gynecology and Obstetrics 105
(2009) 103–104
55. National Comprehensive Cancer Network (NCCN). Cervical Cancer guidelines
56. National Cancer Institute. Cervical Cancer Treatment (PDQ)
57. Alberta Clinical Practice Guidelines
58. BC Cancer Agency (BCCA) guidelines
59. Cancer Care Ontario (CCO) Program
Meeting organizer: Dr. Evgeny Sadikov
Compiler of Guideline: Dr. Evgeny Sadikov and Dr. Carlos Aspe Lucero
Presenters: Dr. Evgeny Sadikov. Dr. Carlos Aspe Lucero, Dr. Saranaya Kakumanu, Dr. Shazia
Mahmood
Moderator: Dr. Shazia Mahmood
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